We are pleased to announce that Global Biomedica s.r.o., a company specializing in advanced spinal solutions, has successfully obtained CE certification in accordance with the European Medical Device Regulation (EU MDR 2017/745) for its flagship product line - BMD Titanium Implant. The BMD Titanium Implant family has undergone rigorous assessment to ensure full compliance … [Read more...] about BMD Titanium Implant Products by Global Biomedica Receive CE Certification under EU MDR
NEWS
Cerapedics Announces FDA Approval of PearlMatrix™ P-15 Peptide Enhanced Bone Graft, The First and Only Proven Bone Growth Accelerator for Lumbar Fusion
WESTMINSTER, Colo., June 23, 2025 /PRNewswire/ -- Cerapedics Inc., a global, commercial-stage orthopedics company dedicated to redefining the path to bone repair, today announced the U.S. Food and Drug Administration (FDA) premarket approval (PMA) of PearlMatrix™ P-15 Peptide Enhanced Bone Graft as a Class III drug-device combination product for use in single-level … [Read more...] about Cerapedics Announces FDA Approval of PearlMatrix™ P-15 Peptide Enhanced Bone Graft, The First and Only Proven Bone Growth Accelerator for Lumbar Fusion
Are There Trends in Spine Surgery? Do we follow what’s best… or just what’s new?
Today,I came across a LinkedIn post about a spine-focused meeting organized by a Spanish company, where the central topic of discussion was whether “trends” or “fashions” exist in spine surgery. This sparked my interest because it’s a highly relevant question in today’s rapidly evolving medical landscape, with new technologies like robotics gaining attention alongside older … [Read more...] about Are There Trends in Spine Surgery? Do we follow what’s best… or just what’s new?
Intrinsic Therapeutics, Inc. Announces That ISASS Has Issued Updated 2025 Recommendations and Coverage Criteria for Barricaid Bone-Anchored Annular Closure
BOSTON, June 19, 2025 /PRNewswire/ -- Intrinsic Therapeutics, a medical technology company committed to redefining the standard of care for lumbar discectomy patients with large annular defects by reducing reoperations for reherniations by 81%* with its Barricaid Annular Closure Device, announced today that the International Society for the Advancement of Spine Surgery (ISASS) … [Read more...] about Intrinsic Therapeutics, Inc. Announces That ISASS Has Issued Updated 2025 Recommendations and Coverage Criteria for Barricaid Bone-Anchored Annular Closure
Expanding Innovations Receives FDA Clearance for N-GAGE™ Lumbar Plate System
Mountain View, CA – June 16, 2025 – Expanding Innovations™ (EI), a rapidly growing spine company specializing in NON-SCREW-based Expandable Technology, today announced U.S. FDA 510(k) clearance for its N-GAGE™ Lumbar Plate System—the company’s first spinal fixation platform as it continues to broaden its procedure-based solutions. The modular, low-profile … [Read more...] about Expanding Innovations Receives FDA Clearance for N-GAGE™ Lumbar Plate System
J&J Hit with $442M Antitrust Verdict Amid Growing Scrutiny Over MedTech Practices
In a closely watched case with industry-wide implications, a federal jury in California has ordered Johnson & Johnson MedTech to pay $442.2 million in damages. The verdict follows an antitrust lawsuit filed by Innovative Health, a company focused on reprocessing FDA-cleared electrophysiology catheters—an area that has seen growing interest from hospitals aiming to balance … [Read more...] about J&J Hit with $442M Antitrust Verdict Amid Growing Scrutiny Over MedTech Practices
Bioactive Porous Technology: The Implant That Comes to Life
How HAPPE Spine is reshaping the future of spinal fusion with a bioactive, porous technology born in a university lab In July 2023, a surgery took place in Indiana that may have quietly opened the door to a new chapter in spine care. Dr. Stephen Smith, a neurosurgeon at Beacon Health System, performed the first implantation of a cervical interbody device unlike anything seen … [Read more...] about Bioactive Porous Technology: The Implant That Comes to Life
ReGelTec Announces First Patient Treated in U.S. IDE Clinical Trial for HYDRAFIL System to Treat Chronic Low Back Pain
BALTIMORE--(BUSINESS WIRE)--ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has treated the first patient in its HYDRAFIL-D FDA investigational device exemption (IDE) clinical trial for its HYDRAFIL® Systemfor disc augmentation. The patient was enrolled by Kas … [Read more...] about ReGelTec Announces First Patient Treated in U.S. IDE Clinical Trial for HYDRAFIL System to Treat Chronic Low Back Pain
ChoiceSpine™ Announces Launch of ChoiceSpine™ App for Surgical Use with eCential Robotics Op.n™ Robotic and Navigation Platform
KNOXVILLE, Tenn. & FRANKLIN, Tenn.--(BUSINESS WIRE)--ChoiceSpine LLC, a privately-held U.S. spinal implant company, in collaboration with eCential Robotics, a leading innovator in surgical robotics, proudly announces the launch of the ChoiceSpine™ application (App) for surgical use on the eCential Op.n™ robotic and navigation platform. This milestone represents a … [Read more...] about ChoiceSpine™ Announces Launch of ChoiceSpine™ App for Surgical Use with eCential Robotics Op.n™ Robotic and Navigation Platform
joimax® Announces Leadership Changes, Expands U.S. Commercial Operations
KARLSRUHE, Germany--(BUSINESS WIRE)--joimax®, the German-based market leader in technologies and methodologies for full-endoscopic and minimally invasive spinal surgery, announces the transition of Founder and long-standing CEO Wolfgang Ries to Executive Chairman and the appointment of Maximilian Ries to Chief Executive Officer. After founding joimax® 24-years ago, Wolfgang … [Read more...] about joimax® Announces Leadership Changes, Expands U.S. Commercial Operations
Aurora Spine Surpasses 1,500 Successful Surgeries Using DEXA-C™
CARLSBAD, CALIFORNIA, June 16, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a leader in innovative spinal implant technology, is proud to announce that its DEXA-C™ system has now been successfully used in more than 1,500 cervical spine procedures across the United States. This milestone … [Read more...] about Aurora Spine Surpasses 1,500 Successful Surgeries Using DEXA-C™
New Study Led by Dr. Kingsley R. Chin Demonstrates Superior Biomechanical Strength of InSpan® Interspinous Fusion Device
FORT LAUDERDALE, Fla., June 16, 2025 /PRNewswire/ -- A landmark biomechanical study led by Harvard-trained orthopedic spine surgeon professor and innovator Dr. Kingsley R. Chin , CEO and Founder of KIC Ventures, validates the InSpan® interspinous fixation device (IFD) as a stronger and more reliable alternative to traditional interspinous designs for spinal … [Read more...] about New Study Led by Dr. Kingsley R. Chin Demonstrates Superior Biomechanical Strength of InSpan® Interspinous Fusion Device
Safe Group announces FDA 510(k) clearance for SpineUp’s Frida solution
Fleurieux-sur-l’Arbresle - France - June 5, 2025 at 6 p.m. Safe Group, a leading player in the field of medical devices for spine surgery, is pleased to announce that Frida, the innovative cervical plate developed by SpineUp, has received 510(k) clearance from the Food and Drug Administration (FDA). This clearance marks a crucial step in SpineUp's expansion into … [Read more...] about Safe Group announces FDA 510(k) clearance for SpineUp’s Frida solution
Aurora Spine Surpasses Milestone of 2,500 Procedures Using SiLO™ SI Joint Fusion System
CARLSBAD, CALIFORNIA, June 10, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a pioneer in innovative spinal solutions, proudly announces that its proprietary SiLO™ Sacroiliac (SI) Joint Fusion System has been successfully used in over 2,500 procedures across the United States. This major … [Read more...] about Aurora Spine Surpasses Milestone of 2,500 Procedures Using SiLO™ SI Joint Fusion System
NanoHive Medical Sublicenses DirectSync’s Piezoelectric Patents to Explore Development of Hive™Soft Titanium® 3D Printed Spine Interbody Fusion “Smart Implant
BOSTON, MA., June 10, 2025 – NanoHive Medical, LLC, a leading innovative 3D printed spinal implant technology company is pleased to announce that the company has secured the exclusive sublicense of DirectSync Surgical’s piezoelectric implantable sensor technology for the field of spinal fusion. DirectSync Surgical had licensed the technology from the University of … [Read more...] about NanoHive Medical Sublicenses DirectSync’s Piezoelectric Patents to Explore Development of Hive™Soft Titanium® 3D Printed Spine Interbody Fusion “Smart Implant
Spineology® Announces the Launch of OptiMesh Align™
ST. PAUL, MN.– Spineology Inc., the pioneers of Conform and Expand™ Technology, today announced the launch of its latest innovation, and most advanced patient specific solution yet: OptiMesh Align (Align). Built on the proven foundation of OptiMesh®, Align is uniquely engineered to provide real time, in-situ, independent anterior and posterior implant expansion resulting in a … [Read more...] about Spineology® Announces the Launch of OptiMesh Align™
Nexxt Spine Announces Key Updates to Executive Leadership Team
NOBLESVILLE, IN, UNITED STATES, June 9, 2025 /EINPresswire.com/ -- Nexxt Spine, LLC, a privately held manufacturer of spinal implants and instrumentation, announced key updates to the Company’s Executive Leadership Team. Ryan Campion has been promoted to Chief Strategy and Development Officer (CSDO); Tom O’Hara has been promoted to Chief Commercial Officer (CCO); Chief People … [Read more...] about Nexxt Spine Announces Key Updates to Executive Leadership Team
(UPDATED 2025): Starting Spine Endoscopy? Best Companies to Consider and Why the Market Is Heating Up!
Endoscopic spinal surgery is becoming an important alternative to traditional open spine surgery by offering less invasive options with faster recovery and fewer complications. This technique uses very small incisions, usually under an inch, along with specialized tubular retractors and a high-definition endoscope to provide surgeons with a clear, magnified view of the spine. … [Read more...] about (UPDATED 2025): Starting Spine Endoscopy? Best Companies to Consider and Why the Market Is Heating Up!
Nanox Receives MDR CE Mark for HealthOST, an Advanced AI-Powered Software for Spine Assessment
PETACH TIKVA, Israel, June 05, 2025 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD ("Nanox" or the "Company", Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd, has received EU MDR CE (Conformité Européenne) mark certification for HealthOST, an SaMD (Software as a medical device) … [Read more...] about Nanox Receives MDR CE Mark for HealthOST, an Advanced AI-Powered Software for Spine Assessment